Facultat de Medicina, University of Barcelona, Barcelona, Spain.
Clínic Institute of Ophthalmology, Clínic Hospital of Barcelona, Sabino de Arana Str., 1, 2Nd Floor (Maternity Hospital), 08028, Barcelona, PC, Spain.
Int Ophthalmol. 2023 Nov;43(11):4181-4195. doi: 10.1007/s10792-023-02828-6. Epub 2023 Sep 12.
This study assessed the effectiveness of the 0.19-mg fluocinolone acetonide (FAc) implant by multimodal measurements in patients with non-infectious uveitis (NIU) in a real-world setting in Spain.
A prospective study of patients who had NIU including uveitic macular oedema (UME) with ≥ 12 months follow-up was done. Exclusion criteria include infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring more than 2 medications. Effectiveness was assessed using a multicomponent outcome measure that included nine outcomes. Effectiveness was defined as all components being met at every timepoint. Secondary outcome measures were onset or progression of glaucoma and investigator-reported adverse events.
Twenty-six eyes from 22 patients were included, with 96.2% having an indication including UME. During the 12-month study, the FAc implant was effective in 15 (57.7%) eyes, reaching effectiveness as soon as 2 weeks post-implantation. Mean best-corrected visual acuity and mean central macular thickness (CMT) were significantly improved vs. baseline at all timepoints (all comparisons p < 0.01). During the 12-month study, inflammation markers (anterior chamber cells and vitreous haze) had also significantly declined. Factors predicting effectiveness at month 12 were systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fibre layer (RNFL) at baseline (all p < 0.05). Factors predicting failure were male gender, thinner RNFL at baseline and treatment ineffectiveness at 1 month (all p < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increase in IOP was detected.
The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.
本研究通过多模态测量评估了 0.19 毫克氟轻松丙酮（FAc）植入物在西班牙真实环境中患有非感染性葡萄膜炎（NIU）患者中的疗效。
对包括葡萄膜炎性黄斑水肿（UME）且随访时间≥12 个月的 NIU 患者进行了前瞻性研究。排除标准包括感染性葡萄膜炎和需要超过 2 种药物治疗的未控制青光眼或眼内压升高。使用包括 9 个结果的多组分结局测量来评估疗效。有效性定义为在每个时间点均满足所有指标。次要结局指标为青光眼的发生或进展以及研究者报告的不良事件。
纳入了 22 例患者的 26 只眼，其中 96.2%有 UME 的适应证。在 12 个月的研究期间，15 只（57.7%）眼的 FAc 植入物有效，植入后 2 周即可达到有效性。与基线相比，所有时间点的最佳矫正视力和中央黄斑厚度（CMT）均显著改善（所有比较 p<0.01）。在 12 个月的研究期间，炎症标志物（前房细胞和玻璃体混浊）也显著下降。在第 12 个月预测有效性的因素为 FAc 前的全身皮质类固醇剂量、基线时更高的免疫调节治疗（IMT）负荷以及基线时更厚的视网膜神经纤维层（RNFL）（均 p<0.05）。预测失败的因素为男性、基线时较薄的 RNFL 和 1 个月时治疗无效（均 p<0.05）。同时，皮质类固醇和 IMT 的使用也显著减少。未发现眼压显著升高。
FAc 植入物在西班牙真实环境中治疗 NIU 12 个月是安全有效的。
